Guest Columns

  1. Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization?

    FDA’s traditional compliance requirements establish a uniform quality system framework, but do not ensure device quality across the ecosystem. Furthermore, a compliance audit will tell a manufacturer whether the system they have established is compliant with current regulations but offers no insight into how they might improve the device, the system, or the development process.

  2. Planned CDRH Reorganization Will Impact Device Approvals and Inspections

    The FDA Center for Devices and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns talent into teams by product type and technology. Find out how this change may affect you. 

  3. The Value Of Standardizing Risk Assessment Across Quality Systems

    Even with the additional effort required and increased complexity, focusing on risk assessment and risk management, and fostering a company culture of continually considering risk, can only improve our overall product quality and sharpen our ability to serve our patients and other stakeholders at the highest level.

  4. Eye Tracking For Better User Interfaces

    Advancements in eye-tracking technologies have made them convenient and affordable to incorporate into user research. Peering into an observer’s perspective can be a valuable source of data for optimizing diverse user interfaces. Few barriers remain to using eye trackers; the only question is how to do so effectively.

  5. Maximizing Clinician Involvement For Improved Device Design

    When considering human factors for medical devices and combination products, running a validation test with the device’s target end users (often clinicians) is universally understood as the primary requirement to meet FDA expectations. However, these activities too often are the extent of clinician involvement in the device lifecycle.

  6. An Analysis Of FDA’s 2017 Enforcement Action Statistics

    FDA's recently published enforcement statistics for FY2017 provide a high-level overview of enforcement actions — including injunctions, seizures, warning letters, and recalls — conducted by all FDA Centers. This article examines the general data from all Centers and then delves into metrics specific to CDRH. 

  7. 6 Mistakes To Avoid During Contextual User Research

    Contextual research is one of the best investments medical device manufacturers can make. Observing and talking to users in their own environments enables deep insights into their needs, preferences, challenges, and barriers. Integrating these insights into device design will lead to better acceptance, adherence, and outcomes — and ultimately, to better market share.

  8. How To Build A Value-Added GMP Supplier Management Program

    For a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation.

  9. Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?

    How do we act on the data of previous 483s? What do we do with that data? Similar to the annual product reviews, we gather data on FDA observations, make graphs, and then … file it away. But there is an alternative.

  10. A Regulatory Perspective: FDA Final Guidance For Design Changes Requiring New 510(k) Submissions

    In response to technological advancements, broadening medical knowledge, and clinical use, medical device designs frequently evolve and come in many forms. Designs often change in response to industry pressure for increased customer satisfaction and device safety, maximized performance, maximized manufacturability, and cost efficiencies.