Guest Columns

  1. New Healthcare Environment Demands An Evolving Approach To R&D

    A more thoughtful approach to product R&D can help to minimize the gap that currently exists between those engaged in the actual practice of healthcare and those performing research, developing, and commercializing medical devices.

  2. ISO 13485:2016 Transition Challenges: A Small Manufacturer Perspective

    The organization’s QMS must have an overarching quality plan -- one that details the elements to be implemented to achieve a successful transition – and must work directly with all the stakeholders involved.

  3. Medical Devices Regulatory Priorities In India

    India’s Medical Device Rules, 2017 have many attractive features that encourage the medical device sector in India. They have been formulated to promote domestic manufacturing and to regulate import and manufacturing in the region. This article examines some of the regulation’s key points to provide a better understanding of its impacts.

  4. Machine-Learning Algorithms Aid In Mapping Neural Signals

    The nervous system contains a wealth of information, and we are only able to record a tiny fraction of it. The quality of the data obtained from these recordings, and how we interpret the data, are critical in accelerating bioelectronic medicine device development.

  5. Think Your Accessory Isn’t A Medical Device? Think Again.

    The FDA guidance Medical Device Accessories – Describing Accessories and Classification Pathways, clarifies much of the confusion regarding accessory classifications, making now a good time to conduct a gap analysis to identify a thorough list of your current and future accessories, and to determine the guidance’s applicability to each.

  6. What Is GDPR’s Effect On Medical Devices?

    The EU’s General Data Protection Regulation (GDPR) will go into full effect on May 25, 2018 — as will penalties for non-compliance. While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves:

  7. A Simplified, Five-Step Approach To Applying FDA’s Human Factors Guidance

    FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices. 

  8. The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

    The FDA’s Software Precertification Pilot Program moves away from the agency’s long-held stance that it does not “approve companies,” exploring new thinking on how to regulate by reputation and continuous improvement loops, rather than reviewing each and every low-risk product. Might there be a way to replicate this type of thinking for complex products?

  9. Market Assessment: Neurovascular Thrombectomy In The U.S. And EU

    Advancements in technology drive continuous improvements in thrombectomy techniques. But, the competitive landscape is subject to change very rapidly, given the release of Medtronic’s aspiration system. 

  10. How To Effectively Work Across Cultures In Global Clinical Trials

    Most of us have spoken to someone and struggled to understand an accent or word choice. Even within a country, different regions can have unique language. So how do you coordinate complex projects across countries and regions, accounting for the differences in culture and honoring common objectives?