Medical Device

Medical Device Industry: Enhancing Efficacy and Patient Experience

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:

Durability Enhancement. Devices are being engineered for increased longevity, reducing or eliminating the need for repeat procedures.
- This requirement places additional emphasis on the fate of the materials and how to successfully validate the planned lifetime.
Combination Products. These innovative products provide therapeutic benefits through targeted pharmaceutical delivery in conjunction with a physical benefit, combining the best of medical device technology and drug therapy.
- The synergies possible from having a device that acts in two different mechanisms places different requirements on the material choices and underlying design of the device.
Personalized Solutions. Custom-manufactured devices are designed to interface seamlessly with patient-specific anatomy, offering tailored treatment options.
- The advent of additive manufacturing and patient scanning has opened the possibility of treatments that are specifically tailored to the unique patient anatomy, but this capability demands a separate set of requirements for validation and verification of the final device.
Minimally Invasive Approaches. Procedures that reduce recovery times and procedural costs are at the forefront of medical device innovation.
- The nature of “keyhole” surgery, or similar small-incision techniques requires a reduction in size of the devices, often pushing the materials close to where they will not behave in the same manner as a bulk material.
Accessibility. Devices are being developed with widespread adoption or at-home care in mind, making healthcare more accessible to a broader population.
- In-hospital usage of devices is an easily controlled situation, but at home, any device will encounter a far more varied and challenging environment, requiring a separate set of choices for materials and designs.

Critical Considerations in Device Development

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.

Material Selection and Characterization

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:

Industry Trends and Challenges

Societal and regulatory pressures are also shaping the way medical devices are developed.

Technology Inertia

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.

Environmental Considerations

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.

Regulatory Landscape

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:

Particulates generated from wear or degradation

PFAS (per- and polyfluoroalkyl substances) presence

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.