Industry Perspectives - Design & Development

  1. Taking Advantage Of RFID’s Expanding Role In Medical Devices

    If one only considers RFID capability as a data carrier, comparable to a bar code, the technology’s growing dynamism is overlooked. With expanded features, greater computing power, lowered costs, and rich data streams, medical and healthcare RFID is innovative, disruptive, and transformative to processes and, potentially, to entire business models.

  2. Beyond Validation: How Meeting Only Minimum Usability Requirements Can Affect Devices After FDA Approval

    Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.

  3. Designing Drug Delivery Devices For Usability

    Usability is a critical factor for all medical devices, but drug delivery devices come with their own unique challenges. Designing for usability requires a clear understanding of user needs and limitations, as well as the environment in which the device will be used.

  4. Are You Asking Product Development Firms The Right Questions?

    If you’re trying to decide whether to hire a product development firm, or determine which one is best for your needs, the key questions you should ask establish a checklist to make sure the firm follows best practices, and reveals more nuanced aspects of how the firm performs its work. 

  5. Qualcomm Partner Provides Telehealth Simplification

    Integron's president discusses how his company developed a growth strategy to approach companies with existing in-home therapies looking to connect their devices. The end result was remote patient monitoring and connected health offerings that have been deployed to 56 countries around the world.

  6. Missed Diagnosis Motivates Entrepreneurial Response

    In his final year of medical school, Matt Kesinger realized that a clinical examination was never going to be good enough for early stroke detection, and he began to develop the technological solution that would become Forest Devices’ ALPHASTROKE.

  7. Genetic Screening, Digital Biomarkers, And Cancer Diagnostics

    This article, focused on the opportunities for innovation in cancer diagnostics, is the last in a four-part series exploring the role of medtech innovation as it pertains to the distinct stages of cancer care.

  8. Implementing Medical Device Cybersecurity: A Two-Stage Process

    Security implementations don’t necessarily need to be complex, but they must be robust and considered. A simple system is more straightforward to validate than a complex one. At a test level, completeness of coverage when testing is a building block to demonstrating that the implementation is robust.

  9. What’s Next In Inhalation Drug Delivery?

    A combination of human-centric design and new sensor, analytics, and data transmission technologies may soon make inhalation devices easier to use, more consistent, and more useful for patients.

  10. Plastics Selection For Medical Wearables: Key Material Families

    The process of material selection often begins by evaluating the characteristics of a given polymer family, and comparing and contrasting them with the characteristics of other polymer families. This evaluation is done in concert with a thorough review of the performance requirements of the device.