Guest Columns

  1. Leveraging AI To Assess Clinical Trial Technologies
    6/13/2019

    As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution. 

  2. Latin America Offers Welcoming Entry Market Amid Tighter EU Regulations
    6/12/2019

    In the past, regulatory requirements that were laxer than U.S. rules made the EU almost a no-brainer as an entry market for many medtechs. However, the advent of the MDR and IVDR has tightened EU regulations and added implementation challenges. Are Latin American markets the answer?

  3. Understanding China’s Updated Overseas Inspections: A Q&A with Gert Bos and Michael Yan
    6/10/2019

    China’s National Medical Products Administration (NMPA) has stepped up overseas inspections in recent years, and manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors.

  4. 7 Tools For Breakthrough Quality And Performance In 30 Days
    6/7/2019

    In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the 7 Tools of Quality.

  5. What Is Taking So Long For Meaningful Interoperability In Clinical Research?
    6/6/2019

    Three decades ago when I entered the profession of clinical research, our workplace equipment extended to typewriters, white-out, mimeographs, hand-written documents, rubber erasers, pens, label makers, and fax and copy machines. Rows of massive, locked, fire-proof filing cabinets storing millions of papers for a nationally funded research program lined record rooms, hallways, and every spare corner of the offices. Most of us felt rewarded when we could use a typewriter with a correction key despite one’s typing skills being firmly judged by the illegible mistakes in the carbon copies.

  6. The Challenge And Promise Of Pediatric Device Innovation
    6/5/2019

    There exist far fewer pediatric devices than adult devices on the market, meaning one of the most vulnerable patient populations also is one of the most underserved. 

  7. Innovation Stimulates Growth In The U.S. Gastrointestinal Endoscopic Device Market
    6/3/2019

    The U.S. gastrointestinal (GI) endoscopic device market is increasingly focusing on specialized procedures, propelling the launch of innovative devices that address unmet medical needs and drive overall market growth.

  8. Developing A Set Of Usability Guidelines For Mobile Health Applications
    5/29/2019

    Most mHealth does not have to meet the FDA requirements for application of human factors and usability engineering. Thus – to date -- the processes used to design and assess mHealth have been widely variable and developer dependent.

  9. Unboxing The Results: The State Of Medical Devices Development Survey 2019
    5/27/2019

    This annual survey of medical device professionals provides insight into how device development has changed in the past 12 months, current views on market challenges and trends, and the potential implications of these findings.

  10. “Work Harder” — And Other Ways To Completely Miss The Mark On Quality
    5/24/2019

    Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.